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NICE seeks comment on PFO closure

This article was originally published in The Gray Sheet

Executive Summary

The U.K.'s National Institute for Health and Clinical Excellence is seeking comments by Aug. 24 on two separate consultation documents on percutaneous patent foramen ovale closure. The first document concluded there is evidence PFO closure is effective in secondary prevention of recurrent paradoxical embolism but also carries a "small incidence" of well-recognized adverse events. The second document finds evidence does not support PFO closure for treatment of recurrent migraine. The target date to publish both guidances is December, NICE says. AGA Medical is studying its Amplatzer PFO occluder in migraine and stroke; NMT Medical is developing the STARFlex PFO device for stroke, but suffered a setback recently when results of a clinical study showed the device was not superior to best medical therapy (1"The Gray Sheet" June 21, 2010)

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Research In Brief

NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes

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